Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...
Integrated sequencing, reagents, and software bring IVDR-compliant sequencing capabilities to European clinical laboratories, with additional ...
Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe’s ...
CINCINNATI, February 24, 2026--(BUSINESS WIRE)--Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad ...
The European Commission’s Medical Device Working Group (MDCG) has published a guidance outlining how the Medical Device Regulation (MDR), In Vitro Diagnostics Regulation (IVDR), and the recently ...
CARLSBAD, Calif.--(BUSINESS WIRE)--To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the ...
YOKNEAM ILIT, Israel, Nov. 27, 2024 /PRNewswire/ -- PixCell Medical, a leading innovator in point-of-care diagnostics, proudly announces that its groundbreaking HemoScreen CBC analyzer has achieved ...
The new regulation, which replaces the earlier IVD Directive 98/79/EC, introduces more rigorous safety, performance, and quality requirements, ensuring that in vitro diagnostic medical devices placed ...
Roche Diagnostics is the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR). TÜV SÜD Product Service issued the IVDR certificate. TÜV ...
Seegene certifies diagnostic assays for digestive, respiratory, women's diseases, and human papillomavirus to meet IVDR requirements New regulation sets improved standards to ensure higher level of ...
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